The present invention relates to a system and method which can be used to provide a physician with information relating to a physical or functional parameter of a tissue opening such as a heart valve, and optionally prepare a valve for a subsequent valve replacement or repair procedure.
Heart valve abnormalities such as valvular insufficiency and valvular stenosis can result in insufficient opening or closure of a heart valve.
Valvular insufficiency is a common cardiac abnormality where the valve leaflets do not completely close. This allows regurgitation (i.e., backward leakage of blood at a heart valve). Such regurgitation requires the heart to pump both the regular volume of blood and the blood that has regurgitated. Such added workload can eventually result in heart failure.
Valvular stenosis or calcification is a calcium buildup in the valve which impedes proper valve leaflet movement and can severely limit opening of the valve.
Traditionally, heart valve abnormalities are treated via open heart surgery, however, in individuals whose heart function is too severely compromised to withstand surgery; percutaneous approaches for treating heart valve disease have been developed.
Percutaneous valvotomy (also called valvuloplasty) is typically performed to treat mitral valve and pulmonic valve stenosis; in some patients it may also be performed to treat stenosis of the aortic valve.
Although valvuloplasty is effective in treatment of mitral and pulmonic valve stenosis, it is not considered effective in treatment of severe symptomatic aortic stenosis; studies have shown that valve replacement is the only viable option for effective treatment. The need for a valve replacement solution combined with the need for minimally invasive surgery has led to the development of percutaneous valve replacement approaches.
Percutaneous valve replacement (PVR) is performed by placing a catheter through the femoral artery (in the groin) or through a radial artery and guiding it into the chambers of the heart. A compressed tissue heart valve is placed on the balloon-mounted catheter and is positioned directly over the diseased aortic valve. Once in position, the balloon is inflated to secure the valve in place.
At present, work on percutaneous valve replacement is proceeding at a pace that reflects intensifying professional and commercial interest. However, this approach is still in the clinical investigational stage and is yet to be accepted as a viable treatment option.
Although percutaneous valve replacement approaches are well known in the prior art, the present inventors believe that there remains a need for a percutaneous valve assessment system which can be used by a physician to determine at least one physical parameter of an abnormal valve and optionally prepare such an abnormal valve for a subsequent valve replacement procedure.